BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4649288 · Received March 26, 2015

    Report

    Report Number
    3008642652-2015-01489
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    July 10, 2014
    Report Date
    March 20, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. THE PT WAS ADMITTED TO THE HOSPITAL FOLLOWING THE EVENT, AND THE PT CONTINUES TO WEAR THE LIFEVEST. DEVICE EVAL WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATED ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. MONITOR SN (B)(4) - 06/2013 (REUSE); ELECTRODE BELT SN (B)(4) - 01/2010 (REUSE). ADD'L INAPPROPRIATE DEFIBRILLATION NARRATIVE: INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE (B)(4). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDED THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT HTTP://WWW.ACCESSDATA.FDA.GOV/CDRA_DOCS/PDF/P010030

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A US DIST CONTACTED ZOLL TO REPORT THAT A PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. A RAPID ATRIAL FIBRILLATION (AF) RATE CONTRIBUTED TO THE FALSE DETECTION. IT WAS REPORTED THAT THE PT WAS AT HOME AT THE TIME OF THE EVENT. THE LIFEVEST DETECTED AN ARRHYTHMIA AT 19:54:28. THE PT'S ECG STRIPS SHOW AF WITH RAPID VENTRICULAR RESPONSE. THE LIFEVEST DELIVERED A DEFIBRILLATION SHOCK A 19:55:32. THE POST-SHOCK RHYTHM WAS AF. THE RESPONSE BUTTONS WERE NOT PRESSED PRIOR TO AND AFTER THE TREATMENT. THE PT WENT TO THE HOSPITAL FOLLOWING THE EVENT AND CONTINUES TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201859 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O